Evaluate Vaccine Agst Chickenpox & a Comb Vaccine Agst 4 Viral Childhood Diseases: Measles, Mumps, Rubella & Chickenpox - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00226499

Purpose

An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition	Intervention	Phase
Rubella Mumps Measles Chickenpox	Biological: Priorix-tetra™ Biological: Priorix™ Biological: Varilrix™	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Study in Healthy Children (<2 Years) to Evaluate the Safety & Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) & of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine

Resource links provided by NLM:

MedlinePlus related topics: Caregivers Chickenpox Measles Mumps Rubella Shingles

Drug Information available for: Measles-Mumps-Rubella Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of confirmed varicella cases in all subjects. [ Time Frame: From 42 days post dose 2 until the end of Phase A ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Phase A:Occurrence of probable or confirmed varicella cases in all subjects [ Time Frame: From 42 days post dose 2 until the end of Phase A ] [ Designated as safety issue: No ]
Occurence of varicella cases by severity in all subjects [ Time Frame: from 42 days post dose 2 until the end of Phase A ] [ Designated as safety issue: No ]
Occurrence of complicated varicella cases (reported as SAEs) in all subjects [ Time Frame: from Day 0 to Year 2 ] [ Designated as safety issue: No ]
Varicella antibody titres in all subjects [ Time Frame: At Day 0, Day 84, Year 1 and Year 2 time points. ] [ Designated as safety issue: No ]
Measles, mumps and rubella antibody titres in a subset of subjects [ Time Frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points. ] [ Designated as safety issue: No ]
Occurrence of SAEs in all subjects [ Time Frame: From Day 0 until the end of Phase A ] [ Designated as safety issue: No ]
Occurrence of herpes zoster in all subjects [ Time Frame: From Day 0 until the end of Phase A ] [ Designated as safety issue: No ]
Occurrence of fever (in a subset of subjects) [ Time Frame: Within 15 days and within 43 days after each vaccination ] [ Designated as safety issue: No ]
Occurrence of any and grade 3 solicited local symptoms (in a subset of subjects) [ Time Frame: Within 4 days after each vaccination ] [ Designated as safety issue: No ]
Occurrence of any and grade 3 solicited general symptoms (in a subset of subjects) [ Time Frame: Within 43 days after each vaccination ] [ Designated as safety issue: No ]
Occurrence of unsolicited symptoms (in a subset of subjects) [ Time Frame: Within 43 days after each vaccination ] [ Designated as safety issue: No ]
Number of hours/days lost from work by parents/guardians as a result of taking care of their child due to varicella [ Time Frame: During Phase A ] [ Designated as safety issue: No ]
Number of hours/days the child lost attendance due to varicella in: day care/childminder, school, or in any extra-curricular activities [ Time Frame: During Phase A ] [ Designated as safety issue: No ]
Number of hours/days spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child due to varicella [ Time Frame: During Phase A ] [ Designated as safety issue: No ]
Phase B:Occurrence of confirmed varicella cases in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ] [ Designated as safety issue: No ]
Occurrence of probable or confirmed varicella cases in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ] [ Designated as safety issue: No ]
Occurrence of varicella cases by severity in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ] [ Designated as safety issue: No ]
Occurence of complicated varicella cases (reported as SAEs) in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ] [ Designated as safety issue: No ]
Varicella antibody titres in all subjects [ Time Frame: At Year 4, Year 6, Year 8 and Year 10 time points ] [ Designated as safety issue: No ]
Measles, mumps and rubella antibody titres in a subset of subjects [ Time Frame: At Year 4, Year 6, Year 8 and Year 10 time points ] [ Designated as safety issue: No ]
Occurrence of SAEs in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ] [ Designated as safety issue: No ]
Occurrence of herpes zoster in all subjects [ Time Frame: From Year 2 to Year 10 after vaccination ] [ Designated as safety issue: No ]
Number of hours/days lost from work by parents/guardians as a result of taking care of their child due to varicella [ Time Frame: During the Phase B period ] [ Designated as safety issue: No ]
Number of hours/days the child lost attendance in: day care/childminder, school, or in any extra-curricular activities due to varicella [ Time Frame: During Phase B ] [ Designated as safety issue: No ]
Number of hours/days spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child. [ Time Frame: During Phase B ] [ Designated as safety issue: No ]

Estimated Enrollment:	6000
Study Start Date:	September 2005
Estimated Study Completion Date:	January 2017
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A	Biological: Priorix-tetra™ 2 IM doses
Experimental: Group B	Biological: Priorix™ 2 IM doses in Group C, 1 IM dose in Group B Biological: Varilrix™ 1 IM dose in Group B
Active Comparator: Group C	Biological: Priorix™ 2 IM doses in Group C, 1 IM dose in Group B

Detailed Description:

According to treatment group allocation, participants will receive study vaccines and be followed for antibody titres and occurrence of varicella disease.

This study is conducted in 2 phases. Phase A includes the vaccination period and an observation period for efficacy. The efficacy endpoints will be evaluated over at least two years after vaccination. During this period, the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella (for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated varicella cases if observed) will be assessed for all subjects during the whole Phase A duration, whereas, solicited (local and general) and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination.

Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and rubella (in a subset of subjects) after vaccination.

Eligibility

Ages Eligible for Study:	11 Months to 22 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study.
Male or female subject between 12 and 22 months of age at the time of the first vaccination.
Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
Subjects whose parents/guardians have direct access to telephone/mobile phone.
Subjects:
1. with at least one sibling (with negative history of varicella disease/vaccination) at home, or
2. attending day care center, or
3. attending childminders, i.e. someone taking care of several children, or
4. who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.

Exclusion criteria:

Previous vaccination against measles, mumps, rubella and/or varicella.
History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases.
Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30 days prior to the start of the study.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical.
Family history of congenital or hereditary immunodeficiency.
History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
Major congenital defects or serious chronic illness.
Residence in the same household as newborns (0-4 weeks of age), pregnant women who are varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella.
History of any neurologic disorders or seizures.
Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.

Additional exclusion criteria for subjects included in the subset:

- Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00226499

Show 99 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00226499 History of Changes
Other Study ID Numbers:	100388, 104105 (EXT FU Y2), 103494 (EXT FU Y1), 104106 (EXT FU Y4-Y6-Y8-Y10)
Study First Received:	September 23, 2005
Last Updated:	October 13, 2011
Health Authority:	Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:

Chickenpox
Measles
Mumps
Parotitis
Rubella
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Morbillivirus Infections
Paramyxoviridae Infections

Mononegavirales Infections
RNA Virus Infections
Rubulavirus Infections
Parotid Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Sialadenitis
Rubivirus Infections
Togaviridae Infections

ClinicalTrials.gov processed this record on February 09, 2012